Healthcare Provider Solutions

With the expanding focus on opioid misuse in this country, hospice has gotten some extra attention regarding its responsibilities in this epidemic. Most all hospices were disposing of unused/unwanted medications of hospice patients who were in their home up until late 2014 when the Disposal of Controlled Substances Act (Disposal Act) was finalized and implemented by the Drug Enforcement Administration (DEA). Prior to this time, there was not much of a question about the commonly accepted practice of hospices disposing of all unused/unwanted medications of home patients, and many hospices viewed it as their duty and a positive step toward reducing the risk of diversion.

The restrictions in the Disposal Act mean that hospice staff can only take possession of the drugs for disposal purposes if that staff person is legally authorized to receive it and dispose of it, such as through a state law or rule. Otherwise, home hospice personnel are not authorized to receive pharmaceutical controlled substances from patients or their family/caregiver for the purpose of disposal.

Few states have laws or rules granting home hospice personnel this authority, but many are considering such laws or rules, often at the urging of hospices.

The Medicare hospice conditions of participation speak to the disposal of drugs but do not address actual disposal/destruction of medications by hospice personnel. The conditions of participation below simply require that the hospice have policies and procedures for the management and disposal of controlled drugs in the patient’s home and that these policies and procedures are provided to the patient, discussed with the patient, and the provision and discussion of the policies and procedures are documented in the patient’s record.

§418.106(e)(2) Disposing. (i) Safe use and disposal of controlled drugs in the patient’s home. The hospice must have written policies and procedures for the management and disposal of controlled drugs in the patient’s home. At the time when controlled drugs are first ordered the hospice must:

§418.106(e)(2)(A) – Provide a copy of the hospice written policies and procedures on the management and disposal of controlled drugs to the patient or patient representative and family;

§418.106(e)(2)(B) – Discuss the hospice policies and procedures for managing the safe use and disposal of controlled drugs with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs; and

§418.106(e)(2)(C) – Document in the patient’s clinical record that the written policies and procedures for managing controlled drugs were provided and discussed.

A hospice in a state that does not provide authority for its personnel to accept drugs for disposal/destruction, will include education at the time of admission explaining safe practices for storing and disposal/destruction of medications. The education is often directly from the US Food and Drug Administration (FDA) and includes a list of medications that are safe for flushing as well as instructions for destruction of the medications and disposal in household trash. The hospice’s policies and procedures also usually will indicate that the hospice will assess for diversion of medications and take steps to prevent it or stop it as necessary.

Overall, the DEA and states are most concerned with the diversion of controlled substances as are hospices. Therefore, hospices should include steps in the policies and procedures to minimize risk for diversion. The steps may include, but are not limited to, the following examples:

  • Counting controlled substances at each visit for each patient, regardless of the risk of diversion in their home.  This practice is helpful for many reasons not just identification of possible diversion but may help to identify diversion early.
  • Limiting the supply of controlled substances.  In situations where diversion is known or suspected, daily deliveries of the controlled substances needed by the patient may be made or limiting the supply to just a couple of days is implemented.
  • Limiting access to the controlled substances.  This may be in the form of a lockbox in the patient’s home with only certain individuals and hospice staff having access.
  • Working with the patient and family to relocate the patient to a more controlled environment such as a nursing home or hospice inpatient unit.

Many hospices have already implemented policies and procedures that include these steps. However, it is not just diversion by patients and families that should be considered in the development of policies and procedures. There is a growing number of healthcare professionals responsible for diversion and this is a primary concern of the DEA. In fact, there have been studies indicating that the rate of drug abuse by healthcare professionals is on the rise and estimating that 1 out of 10 nurses will fall into drug or alcohol abuse at some point in their lives. Hospice agencies and states grappling with this issue must consider all sources of diversion in their policies and procedures. This is not to say that hospice personnel is diverting medications, but it is a possibility that should be considered in hospice policy and procedures. Some hospices have implemented random drug testing for all personnel and, in cases where diversion is suspected in a patient’s home, will remove staff or modify staff assignment. This helps to protect hospice staff as well. For instance, it is not uncommon for a patient’s family to blame hospice staff for missing medications and removing the staff/modifying the staff assignment while continuing to monitor for diversion may show that changing/modifying hospice staff assignment has no impact on missing medications.

Now that hospices have worked under the Drug Disposal Act for a couple of years, some have found an appreciation for not inserting staff into the process of destruction/disposal. They have found that completely removing their staff from the equation minimizes the risk of their staff being accused of diverting medications, minimizes hospice agency liability, and provides legal backup for staff who do not want to be involved in the process.

For those hospices in states where there are no laws or rules directing hospice personnel on their role in disposal/destruction of medications, Healthcare Provider Solutions, Inc. recommends obtaining legal counsel to assist in putting policies and procedures in place for the safe handling and destruction/disposal of controlled substances. We further recommend that these hospices provide information to patients and families on the role hospice has and that its staff cannot accept controlled substances from patients/families.

All hospices, regardless of state laws and rules should provide information on safe disposal and destruction (within confines of the state laws or rules if they exist), which most are already doing, including

  • Guidance from the FDA (linked above) regarding flushing and destruction/disposal of medicines
  • Information on mail-back programs and possibly even providing envelopes for such programs
  • Information on local collection sites (information can be found on the FDA website linked above)
  • Notifying patients/families about local take-back events
  • Notifying patients/families about National Prescription Drug Take-Back Days (the next one is October 28, 2017)

We also recommend that hospices provide education to their staff regarding:

  • How to identify diversion and which substances are most likely to be diverted
  • Hospice policies and procedures and the role hospice staff are legally bound to take in their state
  • What to do in cases where diversion is identified
  • Where to go for help and support for staff misuse of controlled substances

Again, hospices, as a whole, take drug diversion very seriously and desire to assist in minimizing the risk of diversion. They must not do what the law does not allow them to do, so most hospices are only able to educate and instruct patients/families on the safe storage and disposal of medications, including controlled substances.

 

References:

Barajas, 2014 The Healthcare Worker Drug and Substance Abuse Problem, PreCheck Blog https://www.precheck.com/blog/healthcare-worker-drug-and-substance-abuse-problem-in-hospitals

Cobb, 2009 Drug addiction among nurses: Confronting a quiet epidemic, Modern Medicine Network http://www.modernmedicine.com/modern-medicine/news/modernmedicine/modern-medicine-feature-articles/drug-addiction-among-nurses-con?page=full